RESUMO
SINOPSIS: Objetivo: Se realizó un estudio prospectivo, observacional, de seguimiento de casos en el servicio de cirugía plástica del hospital El Tunal, Bogotá, Colombia, para evaluar la efectividad de un apósito de hidrofibra reforzada, con plata iónica al 1,2%, potenciado con ácido etilendiaminotetraacético (EDTA) y cloruro de bencetonio en pacientes con heridas de difícil cicatrización. Método: Se incluyeron 23 pacientes con heridas de diferentes etiologías, signos locales de infección, presencia de exudado e indicadores visuales o indirectos de biofilm. Los pacientes fueron divididos en tres grupos: heridas que requerían cicatrización por segunda intención (n=10) (grupo 1), heridas con absceso (n=4) (grupo 2) y heridas en las que se requería preparar el lecho para cobertura quirúrgica (n=9) (grupo 3). El seguimiento de cada caso duró tres meses. Resultados: El grupo 1 demostró una disminución de exudado, infección y signos indirectos de biofilm, así como una reducción significativa de la superficie de la herida con cierre total en ocho de los 10 casos pertenecientes a este grupo. El grupo 2 logró el control de exudado y cierre de la cavidad en un promedio de 21 días. El grupo 3 obtuvo adecuada preparación del lecho de la herida y alcanzó una cobertura quirúrgica en 15 días, en promedio. No se encontraron efectos adversos en los pacientes tratados. Conclusión: Los resultados muestran que el apósito estudiado es efectivo para controlar exudado, infección y signos indirectos de biofilm, así como para disminuir el tamaño de la herida, lograr el cierre de heridas con absceso y preparar el lecho para una cobertura quirúrgica definitiva. ABSTRACT: Objective: A prospective, observational, case-series study evaluated the efficacy of a hydrofiber dressing with ionic silver, ethylenediaminetetraacetic acid and benzethonium chloride in patients with hard-to-heal wounds at El Tunal hospital in Bogota, Colombia. Method: A total of 23 patients with wounds of different aetiologies, local signs of infection, exudate and biofilm were recruited. Patients were divided into three groups: wounds for secondary intention healing (group 1), abscesses (group 2) and wounds for surgical coverage (group 3). Patients were followed up for 3 months. Results: Group 1 showed a reduction in exudate and infection levels, and a decrease in indirect signs of biofilm. There was also a significant reduction in wound surface, with eight out of 10 patients in this group achieving complete wound closure. Group 2 obtained exudate control and wound closure in 21 days, on average. Group 3 demonstrated an adequate wound bed preparation for surgical coverage in 15 days, on average. No side effects were observed. Conclusion: The results showed that the hydrofiber dressing could be effective in controlling exudate and infection levels, and managing the indirect signs of biofilm, as well as reducing the wound surface, achieving wound closure in abscesses and performing wound bed preparation for surgical coverage.
Assuntos
Anti-Infecciosos Locais/administração & dosagem , Bandagens , Carboximetilcelulose Sódica/administração & dosagem , Infecção dos Ferimentos/prevenção & controle , Adulto , Benzetônio/administração & dosagem , Ácido Edético/administração & dosagem , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Prata/administração & dosagem , Resultado do Tratamento , Infecção dos Ferimentos/patologia , Adulto JovemRESUMO
A double-blind, randomized trial was undertaken in Guatemala to determine the therapeutic efficacy of an ointment for the treatment of cutaneous leishmaniasis that contained 15% paromomycin and 12% methylbenzethonium chloride and that was applied twice a day for 20 days. The treatment group included 35 patients, and the placebo group included 33 patients. The initial clinical response rate (13 weeks after completing the treatment) was 91.4% in the treatment group and 39.4% in the placebo group. The final clinical response rate at the 12-month follow-up examination was 85.7% (31 of 35) in the treatment group and 39.4% (13 of 33) in the placebo group (P < or = 0.001). In general, the treatment was well tolerated and was never interrupted because of adverse effects. The number of adverse effects reported in the placebo group was lower than in the treatment group (16 events versus 30 events). All adverse effects reported by patients disappeared within 1 week of completing the treatment. Our findings show that the combination of paromomycin with methylbenzethonium chloride for 20 days is a good alternative for antimonial treatments of cutaneous leishmaniasis in Guatemala.
Assuntos
Antiprotozoários/administração & dosagem , Benzetônio/análogos & derivados , Benzetônio/administração & dosagem , Leishmaniose Cutânea/tratamento farmacológico , Paromomicina/administração & dosagem , Adolescente , Adulto , Benzetônio/efeitos adversos , Criança , Método Duplo-Cego , Quimioterapia Combinada , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pomadas , Paromomicina/efeitos adversosRESUMO
We determined the efficacy of the combination of the topical formulation 15% paromomycin sulfate/12% methylbenzethonium chloride (MBCL) and a short course (7 days) of parenteral meglumine antimonate (pentavalent antimony [Sb]) as treatment of American cutaneous leishmaniasis in Colombian patients. Patients were randomly assigned in unequal allocation (2:1:1:1) to group 1 (topical paromomycin/MBCL plus injectable Sb for 7 days), group 2 (topical placebo plus injectable Sb for 7 days), group 3 (topical paromomycin/MBCL plus injectable Sb for 3 days), and group 4 (injectable Sb for 20 days). Cure was defined as complete reepithelialization of all lesions without relapse. Cure rates among groups were as follows: 58% (34 of 59), group 1; 53% (16 of 30), group 2; 20% (6 of 30), group 3; and 84% (26 of 31), group 4. Seventy-one percent of the organisms identified to the species level were Leishmania braziliensis panamensis. We conclude that 10 days of therapy with paromomycin/MBCL does not augment the response of cutaneous leishmaniasis (predominately due to L. braziliensis panamensis) to a short course of treatment with meglumine antimonate.
Assuntos
Antiprotozoários/administração & dosagem , Benzetônio/análogos & derivados , Leishmaniose Cutânea/tratamento farmacológico , Meglumina/administração & dosagem , Compostos Organometálicos/administração & dosagem , Paromomicina/administração & dosagem , Benzetônio/administração & dosagem , Método Duplo-Cego , Quimioterapia Combinada , Humanos , Antimoniato de MegluminaRESUMO
Colombian patients with New World cutaneous leishmaniasis were treated with a combination of a topical formulation (15% paromomycin sulfate/5% methylbenzethonium chloride, twice a day) and parenteral meglumine antimonate (20 mg of antimony [Sb]/kg.d]). Cohort 1 received topical therapy for 10 days and Sb for 7 days; 18 (90%) of the 20 patients were cured (follow-up, 12 months). Other clinical data suggested that neither the topical formulation alone nor the 7-day regimen of Sb alone would have cured many patients. In a subsequent cohort, which received topical therapy for 10 days and Sb for 3 days, the cure rate was 42% (eight of 19 patients). In Colombian cohorts (historical controls) treated with Sb alone for 10-15 days, the cure rate was 31%-36%. Side effects in cohort 1 patients consisted of local reactions to the topical formulation: burning and pruritus in 25% of patients and vesicle formation in 15% of patients. This is the first report that a regimen partially composed of topical antimicrobial agents can be highly effective for treatment of New World cutaneous leishmaniasis.
Assuntos
Benzetônio/análogos & derivados , Leishmaniose Cutânea/tratamento farmacológico , Meglumina/administração & dosagem , Compostos Organometálicos/administração & dosagem , Paromomicina/administração & dosagem , Administração Tópica , Adolescente , Adulto , Animais , Antiprotozoários/administração & dosagem , Antiprotozoários/efeitos adversos , Benzetônio/administração & dosagem , Benzetônio/efeitos adversos , Esquema de Medicação , Quimioterapia Combinada , Humanos , Injeções Intramusculares , Injeções Intravenosas , Leishmania braziliensis , Leishmaniose Cutânea/parasitologia , Leishmaniose Mucocutânea/tratamento farmacológico , Leishmaniose Mucocutânea/parasitologia , Masculino , Meglumina/efeitos adversos , Antimoniato de Meglumina , Pessoa de Meia-Idade , Compostos Organometálicos/efeitos adversos , Paromomicina/efeitos adversosRESUMO
Fifty-two patients with American cutaneous leishmaniasis (ACL) from the Pacific coast of Ecuador were treated topically with an ointment containing 15% paramomycin (PR) and 12% methylbenzethonium chloride (MBCL) in vaselinum album (white soft paraffin; white petrolatum). After 20 applications (over 10 or 20 d) all lesions showed complete epithelialization within the first 100 d. Five patients developed new lesions during the one year observation period; 2 of these were probably reinfections. Considering all 5 cases as treatment failures, the healing rates were: 72% after 50 d, 90% after 100 d, and 85% after 360 d. In a separate study in the same area, a group of 23 patients was left without treatment for 3 months. Only 9% of the untreated patients healed spontaneously after 50 d. Growth of the lesion, inflammation and pain were observed at the beginning of treatment. After treatment, most lesions healed rapidly without scars. The drug was well accepted by the patients and was easy to administer under tropical field conditions.